The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as food and not drugs. This is critical to maintaining access to high quality, natural food-supplements. A natural product, by definition, may not be patent-protected. Without the promise of the economic reward that follows successfully patenting a product, it is impossible to weather the new-drug approval process, which can literally cost hundreds of millions of dollars. Thus, if supplements were categorized as drugs and required to go through the new-drug approval process, we would see most of our supplements disappear. Defending DSHEA from attacks by the media, the pharmaceutical industry and elected officials who prefer a pre-market approval approach is a top priority for ANH-USA! ANH-USA has prepared the following primer to help educate those who believe DSHEA should be amended “because supplements are not adequately regulated.”

What is DSHEA?

The Dietary Supplement Health and Education Act of 1994, which spells out regulations regarding the manufacture and sale of dietary supplements, defines a dietary supplement as “a product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient noted in clause (A), (B), (C), (D), or (E).”

The act defines permissible labeling claims and places the burden of proof on the Food and Drug Administration to show that a product is unsafe. It also outlines safety requirements for new dietary ingredients.

Are Dietary Supplements Unregulated?

Absolutely not! DSHEA grants the FDA the authority to regulate dietary supplements in two important respects. First, the FDA regulates product labeling. Whenever a marketer wants to make a claim about a supplement, it must submit the proposed claim to the FDA within 30 days after its first use. Claims are limited to “general structure function” and as a rule may not assert that a product prevents or treats disease. The FDA may stop the manufacturer from advertising the claim if it is deemed impermissible. Second, DSHEA holds supplement manufacturers to what are known as “good manufacturing practices” (i.e., industry standards for maintaining product quality). In addition, the Federal Trade Commission maintains authority over supplement advertising: Manufacturers must report truthfully what their products contain and must have proof backing up any claims they make. Finally, the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 requires what’s known as “adverse event reporting,” the FDA’s way of informing the public about any incidents related to a product once it is on the market. This is the same system of reporting used for FDA-approved drugs and biologics.

ANH-USA’s Position on DSHEA

ANH-USA believes that DSHEA is adequate to protect consumers of dietary supplements from unsafe products but that the FDA has not fully implemented the bill. This lack of full implementation has led to a perception among the public that dietary supplements are unregulated. The answer to this perception is not to grant the FDA more power; it’s for the FDA to fully implement the bill that has already been passed, a bill that grants them all necessary authority over dietary supplements.